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Evidence-Based
Clinical Practice Guidelines
For Staff of
Obstetrics & Gynecology Department
King Khalid University Hospital
2013
PART 1: Introduction
Instructor
Dr. Yasser Sami Amer, MBBCh, MSc
Pediatrician - HC Informatician
Member, G-I-N Adaptation Working Group/Steering Committee
CPGs General Coordinator, QMD, CPG Committee,
King Saud University Hospitals
KKUH/KAUH
Concepts & Definitions
Two Different Approaches to Evidence-Based
Practice (EBP)
Clinical Practice Guidelines (CPGs)
•“Top-down” approach
• Tell clinicians how to practice
• Favored by health care systems
Evidence-Based Medicine (EBM)
•“Bottom-up” approach
• Teach clinicians how to find answers
• Favored by medical educators
EBM definition
The integration of best research evidence
with clinical expertise and patient
values
Sackett et al 2000
Definition: (old)
“Systematically developed statements to assist
practitioner and patient decisions about
appropriate health care for specific clinical
circumstances” (Institute of Medicine 1990).
Increasing international interest in the
development and implementation of CPGs.
Clinical Practice Guidelines (CPGs)
CPGs New Definition
CPGs are “Statements that include
Recommendations intended to optimize
patient care that are informed by a
Systematic Review of evidence and an
assessment of the benefits and harms of
alternative care options”.
Committee on Standards for Developing
Trustworthy CPGs (IOM-AHRQ)
Rationale for CPGs
• Worldwide concerns about:-
▫ Unexplained variations in clinical practice
▫ Rising health care costs
▫ Exponential growth of information
• Aim of CPGs:-
▫ To facilitate more consistent, effective and
efficient practice and improve health
outcomes for patients
Clinical
Care GAP
Best
Practice
• Doctors
• Nurses
• Decision makers
• Patients
• Public
Producers Finders
• Specialized Onco societies:-
• National CPGs agencies:-
 NICE - UK
 SIGN - UK
56 CPGs
Clinical-Obstetrics Antenatal care & pregnancy 19
General 8
Intrapartum Care, Labour & birth 19
Models of care 4
Standards of maternity care 1
The Neonate 3
Clinical-
Gynecology
Cervical Screening & Cervical Cancer 4
Contraception 6
Gynecological Surgery/Procedures 7
Menopause 4
Menstrual Disorder 1
Reproductive Endocrinology 3
Termination of Pregnancy 2
SIGN
Scottish
Intercollegiate
Guidelines Network
www.sign.ac.uk
CPG Producers:
National Agencies
2 CPGs
CPG Producers:
National Agencies
NICE
National Institute for
Health & Clinical
Excellence
www.nice.org.uk
AHRQ
National Guideline
Clearinghouse
www.guidelines.gov
18 CPGs
Guidelines
International
Network
(G-I-N)
www.g-i-n.net
Org. Member since
2009
Shaikh Bahamdan’s Research Chair for Evidence-
Based Health Care & Knowledge Translation
Member of G-I-N since Oct. 2009
Free access to International CPG Library of G-I-N
http://c.ksu.edu.sa/ebhc
http://ebhc.ksu.edu.sa/gin/index.html
PubMed
US National Library of
Medicine
National Institutes of
Health (NIH)
Some CPGs are only retrievable by
“Googling” them!
The Main CPGs Database websites we start searching:-
1- National Guidelines Clearinghouse
(NGC): www.guidelines.gov
2- Guidelines International Network (G-I-N) (International
Library): www.g-i-n.net
3- National Institute of Clinical and Health Excellence
(NICE): http://www.nice.org.uk/guidance/
4- Scottish Intercollegiate Guidelines Network
(SIGN): http://www.sign.ac.uk/guidelines/
5- DynaMed database: Evidence-based clinical
reference https://dynamed.ebscohost.com/
6- National Health and Medical Research Council - Australian
Government: http://www.nhmrc.gov.au/guidelines-
publications
7- Google/ Google Scholar: www.google.com
How do we react to
guidelines?
Read
Adopt
Adapt
Develop
CPGs ?
Topic
Team
Content
Search
FOUND NOT FOUND
Appraise Develop
AppraiseAdopt or Adapt
Implement
Evaluate impact
Adaptation of Clinical Practice Guidelines
The ADAPTE collaboration is an
international collaboration of CPG researchers, developers and
implementers. Their main aim is to develop and validate a
generic adaptation process that will foster valid and high-quality
adapted guidelines as well as the user’s sense of ownership of
the adapted guideline.
Guideline Adaptation
• Is the systematic approach to the endorsement and/or
modification of a guideline(s) produced in one cultural
and organizational setting for application in a different
context. Adaptation may be used as an alternative to
de novo guideline development, e.g., for customizing
(an) existing guideline(s) to suit the local context.
• http://www.adapte.org/
©Copyright ADAPTE 2007
We identified 3 main ADAPTE steps:-
Adaptation Phase
Search & Selection of source CPGs
Health Questions (PIPOH)
AGREE II Instrument
Assess source CPGs quality
External Review
(Departmental Consensus)
We expect your invaluable input through assigning
The Obs. & Gyn. CPG Subcommittee/team members
representing each of your divisions (subspecialties):-
1 General Obs/Gyn
2 Oncology
3 Maternal Fetal Medicine
4 Assisted Reproduction
5 Uro-gynecology
CPG Scope: PIPOH Model
Patient (& disease characteristics)
Intervention(s)
Professionals (Target users)
Outcomes (purpose of the CPGs)
Healthcare settings (& context)
= Health/ Clinical/ Key Questions
Evidence Pyramid
MA
RCT
Cohort
Case control
Case series
Case report
Expert opinion
I
II
III
IV
A
B
C
LevelsofEvidence
GradesofRecommendations
How to assess of the quality of any CPG ?
Assess guideline
quality
ADAPTE TOOL 9 AGREE II
Instrument
23 items in 6 domains
7 point response scale
Domain scores
Recommendations
Considerations before a CPG
Assessment
• increase the reliability of the assessment
2 – 4 Appraisers
• in full and obtain all related information and
needed documents before undertaking the
AGREE II assessment ( to make a well
informed assessment)
Read CPG first
23 Items in 6 Domains
USER’S MANUAL page 7
DOMAINS No. of Items
1 Scope & Purpose 3
2 Stakeholder Involvement 3
3 Rigour of Development 8
4 Clarity & Presentation 4
5 Applicability 3
6 Editorial Independence 2
7. Systematic methods for E
search
8. Selection Criteria of E
9. Strengths & Limitations of E
10. Methods of Rs
11. Benefits , side effect and risks
in Rs
12. Evidence Links (Gs of Rs –
LoE)
13. External Review
14. Update Procedure
DOMAIN 3. RIGOUR OF DEVELOPMENT
Methods, literature search
strategy & appendices
+ inclusion/ exclusion criteria
+ Evidence tables, clinical
evidence, evidence description
(results), evidence
interpretation (discussion)
Methods, CPG Development
process
 same sections
+ Rs, Key Evidence
+ acknowledgements
+ CPG update, date of CPG
AGREE Enterprise website
http://www.agreetrust.org/
CPGs: 1 (or 2) documents
FIRST (Clinicians’ Version)
• Accessible from ALL points-of-care
for the hospital staff:
• Details of evidence-based
recommendations for management
(with only references to the other
document)
SECOND:
(Methodologist’s Version) ;
• Accessible from Libraries
of e.g.
Department, College of
Medicine, CPG
Committee, QMD, Authors
hip group,…etc. (Reference for
Replication & Documentation)
• Detailed description of the
CPG Adaptation process
with ALL relevant data.
Dissemination & Implementation
Nothing could be more
frustrating than producing
a CPG that is then ignored
by not being disseminated
nor implemented
Dissemination of CPGs
• External Review
• Full CPGs documents published on websites
• Implementation tools will also be published:
examples for choice:-
1. Quick Reference Guide (Summary Key Rs)
2. Clinical Algorithms (decision tree)
3. Clinical pathways (Integrated care pathways)
4. Order Sets
5. Patient Information (Education Guide) Arabic
6. Clinical Audit Tool
7. CPOE (Computerized Physician Order Entrty) = e-
SIHI (New HIS)
8. ICD – 10 Codes
• If CPGs are to have a positive impact on
patient care outcomes they must be
implemented and incorporated into
everyday clinical practice
• The identification of any barriers to
implementation, and strategies for
overcoming them, will form an essential
part of discussions at CPGs
Subcommittee/ Adaptation Group
meetings
Implementing Guidelines
Obstetrics & Gynecology
Clinical Practice Guidelines
Subcommittee
Multidisciplinary !
TEAM WORK
TEAM
TOGETHER
EVERYONE
ACHIEVES
MORE
Participating/ promoting EBCPGs/ EBHC
WIN – WIN !MY
PATIENTS/
CLIENTS
MY
DEPARTMENT
MY
HOSPITAL
WIN – WIN !
Participating/ promoting EBCPGs/ EBHC
1) Improve our Life-long learning & Information Mastery
Skills
2) Improve our informed Clinical Decisions
3) Improve our patients (customers) outcomes
4) Improve our UG/ PG Teaching tools
5) Authorship of Publication (CPG Book/ Article)
6) Organizational Member in G-I-N
7) KSUHs EBCPGs Champions
8) Honoraria (Incentives),…and more!
Dr. Yasser Sami Amer
MSc Pediatrics, MSc HC Informatics
CPGs G. Coordinator,
QMD, CPGC, KKUH/ KAUH

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Evidence-Based Clinical Practice Guidelines for OBSTETRICS AND GYNECOLOGY

  • 1.
  • 2. Evidence-Based Clinical Practice Guidelines For Staff of Obstetrics & Gynecology Department King Khalid University Hospital 2013 PART 1: Introduction Instructor Dr. Yasser Sami Amer, MBBCh, MSc Pediatrician - HC Informatician Member, G-I-N Adaptation Working Group/Steering Committee CPGs General Coordinator, QMD, CPG Committee, King Saud University Hospitals KKUH/KAUH
  • 4. Two Different Approaches to Evidence-Based Practice (EBP) Clinical Practice Guidelines (CPGs) •“Top-down” approach • Tell clinicians how to practice • Favored by health care systems Evidence-Based Medicine (EBM) •“Bottom-up” approach • Teach clinicians how to find answers • Favored by medical educators
  • 5. EBM definition The integration of best research evidence with clinical expertise and patient values Sackett et al 2000
  • 6.
  • 7. Definition: (old) “Systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances” (Institute of Medicine 1990). Increasing international interest in the development and implementation of CPGs. Clinical Practice Guidelines (CPGs)
  • 8. CPGs New Definition CPGs are “Statements that include Recommendations intended to optimize patient care that are informed by a Systematic Review of evidence and an assessment of the benefits and harms of alternative care options”. Committee on Standards for Developing Trustworthy CPGs (IOM-AHRQ)
  • 9.
  • 10. Rationale for CPGs • Worldwide concerns about:- ▫ Unexplained variations in clinical practice ▫ Rising health care costs ▫ Exponential growth of information • Aim of CPGs:- ▫ To facilitate more consistent, effective and efficient practice and improve health outcomes for patients
  • 12.
  • 13. • Doctors • Nurses • Decision makers • Patients • Public
  • 14.
  • 16. • Specialized Onco societies:- • National CPGs agencies:-  NICE - UK  SIGN - UK
  • 18.
  • 19. Clinical-Obstetrics Antenatal care & pregnancy 19 General 8 Intrapartum Care, Labour & birth 19 Models of care 4 Standards of maternity care 1 The Neonate 3 Clinical- Gynecology Cervical Screening & Cervical Cancer 4 Contraception 6 Gynecological Surgery/Procedures 7 Menopause 4 Menstrual Disorder 1 Reproductive Endocrinology 3 Termination of Pregnancy 2
  • 21. CPG Producers: National Agencies NICE National Institute for Health & Clinical Excellence www.nice.org.uk
  • 24. Shaikh Bahamdan’s Research Chair for Evidence- Based Health Care & Knowledge Translation Member of G-I-N since Oct. 2009 Free access to International CPG Library of G-I-N
  • 27.
  • 28.
  • 29. PubMed US National Library of Medicine National Institutes of Health (NIH)
  • 30. Some CPGs are only retrievable by “Googling” them!
  • 31. The Main CPGs Database websites we start searching:- 1- National Guidelines Clearinghouse (NGC): www.guidelines.gov 2- Guidelines International Network (G-I-N) (International Library): www.g-i-n.net 3- National Institute of Clinical and Health Excellence (NICE): http://www.nice.org.uk/guidance/ 4- Scottish Intercollegiate Guidelines Network (SIGN): http://www.sign.ac.uk/guidelines/ 5- DynaMed database: Evidence-based clinical reference https://dynamed.ebscohost.com/ 6- National Health and Medical Research Council - Australian Government: http://www.nhmrc.gov.au/guidelines- publications 7- Google/ Google Scholar: www.google.com
  • 32. How do we react to guidelines?
  • 34. Topic Team Content Search FOUND NOT FOUND Appraise Develop AppraiseAdopt or Adapt Implement Evaluate impact
  • 35.
  • 36. Adaptation of Clinical Practice Guidelines The ADAPTE collaboration is an international collaboration of CPG researchers, developers and implementers. Their main aim is to develop and validate a generic adaptation process that will foster valid and high-quality adapted guidelines as well as the user’s sense of ownership of the adapted guideline.
  • 37. Guideline Adaptation • Is the systematic approach to the endorsement and/or modification of a guideline(s) produced in one cultural and organizational setting for application in a different context. Adaptation may be used as an alternative to de novo guideline development, e.g., for customizing (an) existing guideline(s) to suit the local context. • http://www.adapte.org/
  • 39. We identified 3 main ADAPTE steps:- Adaptation Phase Search & Selection of source CPGs Health Questions (PIPOH) AGREE II Instrument Assess source CPGs quality External Review (Departmental Consensus)
  • 40. We expect your invaluable input through assigning The Obs. & Gyn. CPG Subcommittee/team members representing each of your divisions (subspecialties):- 1 General Obs/Gyn 2 Oncology 3 Maternal Fetal Medicine 4 Assisted Reproduction 5 Uro-gynecology
  • 41. CPG Scope: PIPOH Model Patient (& disease characteristics) Intervention(s) Professionals (Target users) Outcomes (purpose of the CPGs) Healthcare settings (& context) = Health/ Clinical/ Key Questions
  • 42.
  • 43. Evidence Pyramid MA RCT Cohort Case control Case series Case report Expert opinion I II III IV A B C LevelsofEvidence GradesofRecommendations
  • 44. How to assess of the quality of any CPG ?
  • 45. Assess guideline quality ADAPTE TOOL 9 AGREE II Instrument 23 items in 6 domains 7 point response scale Domain scores Recommendations
  • 46. Considerations before a CPG Assessment • increase the reliability of the assessment 2 – 4 Appraisers • in full and obtain all related information and needed documents before undertaking the AGREE II assessment ( to make a well informed assessment) Read CPG first
  • 47. 23 Items in 6 Domains USER’S MANUAL page 7 DOMAINS No. of Items 1 Scope & Purpose 3 2 Stakeholder Involvement 3 3 Rigour of Development 8 4 Clarity & Presentation 4 5 Applicability 3 6 Editorial Independence 2
  • 48. 7. Systematic methods for E search 8. Selection Criteria of E 9. Strengths & Limitations of E 10. Methods of Rs 11. Benefits , side effect and risks in Rs 12. Evidence Links (Gs of Rs – LoE) 13. External Review 14. Update Procedure DOMAIN 3. RIGOUR OF DEVELOPMENT Methods, literature search strategy & appendices + inclusion/ exclusion criteria + Evidence tables, clinical evidence, evidence description (results), evidence interpretation (discussion) Methods, CPG Development process  same sections + Rs, Key Evidence + acknowledgements + CPG update, date of CPG
  • 50. CPGs: 1 (or 2) documents FIRST (Clinicians’ Version) • Accessible from ALL points-of-care for the hospital staff: • Details of evidence-based recommendations for management (with only references to the other document)
  • 51. SECOND: (Methodologist’s Version) ; • Accessible from Libraries of e.g. Department, College of Medicine, CPG Committee, QMD, Authors hip group,…etc. (Reference for Replication & Documentation) • Detailed description of the CPG Adaptation process with ALL relevant data.
  • 52. Dissemination & Implementation Nothing could be more frustrating than producing a CPG that is then ignored by not being disseminated nor implemented
  • 53. Dissemination of CPGs • External Review • Full CPGs documents published on websites • Implementation tools will also be published: examples for choice:- 1. Quick Reference Guide (Summary Key Rs) 2. Clinical Algorithms (decision tree) 3. Clinical pathways (Integrated care pathways) 4. Order Sets 5. Patient Information (Education Guide) Arabic 6. Clinical Audit Tool 7. CPOE (Computerized Physician Order Entrty) = e- SIHI (New HIS) 8. ICD – 10 Codes
  • 54. • If CPGs are to have a positive impact on patient care outcomes they must be implemented and incorporated into everyday clinical practice • The identification of any barriers to implementation, and strategies for overcoming them, will form an essential part of discussions at CPGs Subcommittee/ Adaptation Group meetings Implementing Guidelines
  • 55. Obstetrics & Gynecology Clinical Practice Guidelines Subcommittee Multidisciplinary ! TEAM WORK
  • 57. Participating/ promoting EBCPGs/ EBHC WIN – WIN !MY PATIENTS/ CLIENTS MY DEPARTMENT MY HOSPITAL
  • 58. WIN – WIN ! Participating/ promoting EBCPGs/ EBHC 1) Improve our Life-long learning & Information Mastery Skills 2) Improve our informed Clinical Decisions 3) Improve our patients (customers) outcomes 4) Improve our UG/ PG Teaching tools 5) Authorship of Publication (CPG Book/ Article) 6) Organizational Member in G-I-N 7) KSUHs EBCPGs Champions 8) Honoraria (Incentives),…and more!
  • 59. Dr. Yasser Sami Amer MSc Pediatrics, MSc HC Informatics CPGs G. Coordinator, QMD, CPGC, KKUH/ KAUH